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International Conference on Harmonisation (ICH) is the international body comprising regulatory agencies and pharmaceutical industry experts in Europe, US and Japan that defines standards within scientific and technical aspects of drug registration, including setting standards for the format and content of regulatory documentation.
Good Clinical Practice (GCP) is a standard defined by ICH for the design, conduct, performance, monitoring, auditing and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected (CDISC v9.0)
Trilogy writers are fully conversant with International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) standards that apply to activities of medical writing, as well as European, US, and other local regulatory requirements and all our documentation complies with these standards.
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